Trials / Recruiting
RecruitingNCT06616844
IDEAL: Efficacy of Porcine Placental Extracellular Matrix Augmented Plus Standard of Care (SOC) Versus SOC Alone for the Management of Diabetic Foot Ulcers
Evaluating the Efficacy of Porcine Placental Extracellular Matrix Augmented Wound Care Against Standard Wound Care for the Management of Diabetic Foot Ulcers: A Multi-center, Prospective, Observer-blinded, Randomized Controlled Clinical Trial.
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 194 (estimated)
- Sponsor
- ConvaTec Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
A multi-center, prospective, observer-blinded, randomized controlled clinical trial to evaluate the efficacy of PPECM augmented standard of care versus standard of care alone in the management of hard-to-heal diabetic foot ulcers.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | InnovaMatrix® AC | SOC plus weekly application of the study device |
Timeline
- Start date
- 2025-02-12
- Primary completion
- 2026-02-01
- Completion
- 2026-07-01
- First posted
- 2024-09-27
- Last updated
- 2025-05-21
Locations
9 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06616844. Inclusion in this directory is not an endorsement.